Ebb & Flow
Three highly anticipated sets of Phase III data were announced last week: for exenatide LAR to treat Type II diabetes, for Viveta treprostinil to treat pulmonary arterial hypertension and for Orplatna satraplatin to treat prostate cancer.
One was a blow up, with predictable results for GPC (FSE:GPC; GPCB). Of the two successes, only United Therapeutics (UTHR) was rewarded by the market, while Amylin (AMLN) was penalized for not rewarding expectations.
The problem for AMLN's trial of once-daily exenatide LAR, versus its twice-daily counterpart Byetta, was that LAR wasn't as superior as investors had hoped.
In the 30-week trial in 295 patients, patients who received LAR showed a statistically significant improvement from baseline (1.9%) in HbA1c vs. those who received Byetta (1.5%). After 30 weeks, both treatment groups lost an average of 8 pounds. The incidence of nausea was about 30% lower for exenatide LAR than for Byetta.
But investors had expected more.
"It seems like it's only marginally superior, so the only benefit that you have is the convenience," noted Maxim Jacobs of Ridgemark Capital.
"The expectation for the delta between the two arms was that it would be larger," said Evan McCulloch of Franklin Templeton.
On a conference call, AMLN President and CEO Daniel Bradbury said the Byetta arm performed better than in previous studies, which was likely due to the open-label design as well as high retention and compliance rates.
"The bottom line is that we saw the best results that we've ever seen with Byetta in this study, both in terms of glucose control and weight loss," he concluded.
According to Byetta's label, in a 30-week trial a high dose resulted in a 0.8% improvement in HbA1c from baseline. Last week's outcome was nearly twice that. Similarly, weight loss in the label study was 2.8 pounds, less than half that in the data presented last week.
An NDA submission is planned for 1H09. With LAR not expected to be on the market until at least 2010, both McCulloch and Jacobs suggested the lack of a clear treatment advantage leaves the door open for once-daily competitors.
Each mentioned BIM 51077, a glucagon-like peptide-1 (GLP-1) analog to treat Type II diabetes from Roche (SWX:ROG) and Ipsen (Euronext:IPN), with Japanese marketing rights shared by Teijin Pharma.Phase IIb data for the compound are expected by year end. The subcutaneously injected candidate is being tested in once-daily, once-a-week and once-every-two weeks regimens.
LAR uses Medisorb drug delivery technology from Alkermes (ALKS). AMLN was off $4.03 to $43.15 on the week. ALKS was down $3.03 (18%) to $14.19, despite reporting earnings that beat consensus estimates (see "EPS Watch," A21).
AMLN and Eli Lilly(LLY) market Byetta.
While expectations were high for LAR, there